Regulatory Affairs Newsletter Archive – Page 150

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BSI webinar on EU IVDR regulatory updates

BSI are hosting a webinar about the latest IVDR regulatory updates on 28 November. The webinar will include a short recap on where the IVDR is, along with latest MDCG guidance and developments in Brussels; description of the challenges for Class D IVD’s and the status on EU Reference Labs and envision the potential ramifications for manufacturers of these updates.…

adminNovember 24, 2023

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DEFRA update on Modulated Fees

DEFRA have provided the following information on future assessment criteria for Modulating Fees and the packaging information needs of all parties involved in the end-to-end production of goods: Over 100 people from a wide range of interest groups took part in a Modulated Fees visioning event held on 24 October 2023, including representatives from the Welsh Government, trade associations, North…

adminNovember 24, 2023

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MHRA weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Access Consortium Page summary: The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic. Change made: Added details of the Access Consortium’s Advanced Therapy Medicinal Products Working Group. Medical devices given exceptional use authorisations during the COVID-19…

adminNovember 17, 2023

UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Biomanufacturing Fund (BMF): phase 2 open to expressions of interest Page summary: This fund is to support commercial-scale vaccines and biotherapeutics manufacturing projects that will improve the UK’s health resilience for future pandemics. Change made: Deadline to submit a Expression of Interest (EOI) form changed to 12pm (midday) on Friday…

adminNovember 17, 2023

APHA weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Export processed animal protein and rendered fat from non-ruminant animals to Malaysia: certificate 8748 updated Page summary: Apply online to export processed animal protein (PAP) and rendered fat from non-ruminant animals that is not intended for human consumption to Malaysia Change made: Updated NFG Apply for an export health certificate…

adminNovember 17, 2023

DEFRA weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. UK REACH: alternative transitional registration model (ATRm) Page summary: Outlines our plans for an alternative transitional registration model (ATRm) for UK REACH. Change made: First published. Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved…

adminNovember 17, 2023

OPSS weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Weights and measures: national and EEC stamp numbers Page summary: Listings of numbers for identifying items of weighing or measuring equipment. Change made: List of authorised stamp numbers updated. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made:…

adminNovember 17, 2023

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DHSC weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. UK Statement at 7th Intergovernmental Negotiating Body Page summary: UK opening intervention at the 7th Intergovernmental Negotiating Body. Delivered by the UK’s Ambassador to the WTO and UN, Simon Manley, on 6 November 2023. Change made: First published.

adminNovember 17, 2023

UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with two additions. Customs, VAT and excise UK transition legislation from 1…

adminNovember 17, 2023

Office for Life Sciences – publications (WC 13 Nov)

The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 16 November These include updates on news, including regulatory updates, transitional guidance and events.

adminNovember 17, 2023